DACARBAZINE

N/A

Manufactured by Fresenius Kabi USA, LLC

12,161 FDA adverse event reports analyzed

Last updated: 2026-04-15

About DACARBAZINE

DACARBAZINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. The most commonly reported adverse reactions for DACARBAZINE include FEBRILE NEUTROPENIA, OFF LABEL USE, NEUTROPENIA, PYREXIA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DACARBAZINE.

Top Adverse Reactions

FEBRILE NEUTROPENIA607 reports
OFF LABEL USE572 reports
NEUTROPENIA479 reports
PYREXIA372 reports
DRUG INEFFECTIVE313 reports
DISEASE PROGRESSION290 reports
NEUROPATHY PERIPHERAL283 reports
NAUSEA272 reports
ANAEMIA243 reports
PRODUCT USE IN UNAPPROVED INDICATION238 reports
VOMITING226 reports
DIARRHOEA220 reports
THROMBOCYTOPENIA214 reports
MALIGNANT NEOPLASM PROGRESSION203 reports
SEPSIS200 reports
PULMONARY TOXICITY199 reports
PNEUMONIA196 reports
HODGKIN^S DISEASE189 reports
DYSPNOEA185 reports
ACUTE MYELOID LEUKAEMIA184 reports
FATIGUE183 reports
ABDOMINAL PAIN176 reports
DEATH157 reports
SECOND PRIMARY MALIGNANCY153 reports
RESPIRATORY FAILURE144 reports
NEUTROPHIL COUNT DECREASED130 reports
LEUKOPENIA127 reports
PANCYTOPENIA127 reports
INTERSTITIAL LUNG DISEASE126 reports
WHITE BLOOD CELL COUNT DECREASED121 reports
TOXICITY TO VARIOUS AGENTS114 reports
INFECTION110 reports
PAIN104 reports
TACHYCARDIA103 reports
PNEUMONITIS100 reports
COUGH99 reports
CONSTIPATION98 reports
ASTHENIA97 reports
DEHYDRATION93 reports
GENERAL PHYSICAL HEALTH DETERIORATION93 reports
CARDIOTOXICITY92 reports
HYPOTENSION92 reports
MUCOSAL INFLAMMATION91 reports
HEADACHE89 reports
LUNG DISORDER87 reports
ARTHRALGIA86 reports
MYELOSUPPRESSION86 reports
BACK PAIN85 reports
MYELODYSPLASTIC SYNDROME85 reports
RASH85 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA84 reports
SEPTIC SHOCK84 reports
COLITIS82 reports
BONE PAIN80 reports
HYPOTHYROIDISM80 reports
NEOPLASM PROGRESSION80 reports
DIZZINESS76 reports
MYALGIA76 reports
FOETAL EXPOSURE DURING PREGNANCY74 reports
MALAISE73 reports
CHILLS70 reports
PLATELET COUNT DECREASED69 reports
DECREASED APPETITE68 reports
FALL68 reports
DRUG INTOLERANCE67 reports
EXPOSURE DURING PREGNANCY67 reports
PREMATURE BABY67 reports
CHEST PAIN66 reports
CONDITION AGGRAVATED66 reports
LYMPHADENOPATHY66 reports
PRODUCT USE ISSUE66 reports
ACUTE KIDNEY INJURY65 reports
CARDIAC FAILURE65 reports
DRUG INTERACTION65 reports
ALANINE AMINOTRANSFERASE INCREASED63 reports
CANDIDA INFECTION63 reports
THERAPY PARTIAL RESPONDER61 reports
TREATMENT FAILURE61 reports
HYPOAESTHESIA60 reports
DEEP VEIN THROMBOSIS59 reports
PLEURAL EFFUSION59 reports
PAIN IN EXTREMITY57 reports
CYTOPENIA56 reports
DYSPHAGIA56 reports
PULMONARY EMBOLISM56 reports
ASPARTATE AMINOTRANSFERASE INCREASED54 reports
DISEASE RECURRENCE54 reports
HODGKIN^S DISEASE RECURRENT54 reports
LOSS OF CONSCIOUSNESS53 reports
HYPERHIDROSIS52 reports
HYPERTENSION52 reports
URINARY TRACT INFECTION52 reports
HAEMOGLOBIN DECREASED51 reports
PULMONARY FIBROSIS51 reports
FEBRILE BONE MARROW APLASIA50 reports
HYPONATRAEMIA50 reports
WEIGHT DECREASED50 reports
STOMATITIS49 reports
HAEMATOTOXICITY48 reports
HEPATOTOXICITY48 reports

Report Outcomes

Out of 7,108 classified reports for DACARBAZINE:

Serious 95.0%Non-Serious 5.0%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male2,969 (53.8%)
Female2,479 (44.9%)
Unknown69 (1.3%)

Reports by Age

Age 35124 reports
Age 40116 reports
Age 4999 reports
Age 5794 reports
Age 3093 reports
Age 6789 reports
Age 6088 reports
Age 3987 reports
Age 3286 reports
Age 3685 reports
Age 2184 reports
Age 6983 reports
Age 3382 reports
Age 3482 reports
Age 5482 reports
Age 6881 reports
Age 3180 reports
Age 5577 reports
Age 5876 reports
Age 6176 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with DACARBAZINE?

This profile reflects 12,161 FDA FAERS reports that mention DACARBAZINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DACARBAZINE?

Frequently reported terms in FAERS include FEBRILE NEUTROPENIA, OFF LABEL USE, NEUTROPENIA, PYREXIA, DRUG INEFFECTIVE, DISEASE PROGRESSION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DACARBAZINE?

Labeling and FAERS entries often list Fresenius Kabi USA, LLC in connection with DACARBAZINE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.